Brooke Chapman, Marie Sinclair, Avik Majumdar, Catherine Yu, James Widdop, Rudolf Hoermann, Kate Collins, Ryma Terbah, Katrina Tan, Adam Testro
{"title":"Real-world experience of home continuous terlipressin infusion for complications of portal hypertension.","authors":"Brooke Chapman, Marie Sinclair, Avik Majumdar, Catherine Yu, James Widdop, Rudolf Hoermann, Kate Collins, Ryma Terbah, Katrina Tan, Adam Testro","doi":"10.14309/ajg.0000000000003589","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003589","url":null,"abstract":"<p><strong>Background aims: </strong>Home continuous terlipressin infusion (CTI) is an emerging therapy for the treatment of portal hypertensive complications in decompensated cirrhosis. This study presents efficacy and safety data of long-term CTI in a longitudinal cohort.</p><p><strong>Methods: </strong>All patients treated with at least 2 weeks of home CTI for portal hypertensive complications between 2013-2023 were included. Recorded data include handgrip strength (HGS), weight, serum biochemistry, and paracentesis frequency pre- and during CTI. Adverse events related to CTI as well as unplanned readmissions before and during CTI were recorded. Patients were followed until liver transplantation, CTI cessation, death, or census date.</p><p><strong>Results: </strong>One hundred and two transplant-eligible patients with median MELD-Na 24 (IQR 20-29) were treated with CTI for 84 (58-151) days. Compared to pre-CTI, HGS increased by 2.84kg [95% CI 1.89-3.80], whilst body weight reduced by 10.6kg [95% CI -12.70 to -8.52] (both p<0.0001). Paracentesis frequency reduced by 58% (p=0.006) and median creatinine by 0.61mg/dL [95% CI -0.87 to -0.3] (p<0.001). Serum sodium did not significantly change. Over a cumulative total of 12,312 days, 49 treatment-related adverse events were recorded in 36 patients, 84% of which were central line-related. There were no vascular events, episodes of pulmonary oedema or events requiring treatment cessation.</p><p><strong>Conclusion: </strong>This study demonstrates the safety of home CTI in a real-world cohort of over 100 well-selected transplant-eligible patients with decompensated cirrhosis. It confirms previous findings that long-term CTI is associated with increased HGS and reduced paracentesis, in addition to its established benefit on renal function. These data provide strong clinical rationale for further prospective randomized trials to investigate the use of CTI as a bridge to liver transplant.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christina D Chambers, Diana L Johnson, Yunjun Luo, Ronghui Xu, Margaret P Adam, Stephen R Braddock, Kenneth Lyons Jones
{"title":"Birth outcomes in women who have taken vedolizumab in pregnancy: results from the Vedolizumab Pregnancy Exposure Registry.","authors":"Christina D Chambers, Diana L Johnson, Yunjun Luo, Ronghui Xu, Margaret P Adam, Stephen R Braddock, Kenneth Lyons Jones","doi":"10.14309/ajg.0000000000003593","DOIUrl":"10.14309/ajg.0000000000003593","url":null,"abstract":"<p><p>There are limited data on the safety of vedolizumab in pregnancy for the treatment of Crohn's disease or ulcerative colitis. Between 2015 and 2022, the Organization of Teratology Information Specialists (OTIS) conducted a prospective, observational pregnancy registry study with 275 pregnant women residing in the U.S. or Canada. Women were enrolled in one of three cohorts: vedolizumab-exposed (N=99); disease-matched unexposed to vedolizumab, but treated with another biologic in pregnancy (N=76); or unexposed with no chronic health conditions (N=100). Women and their infants were followed up to one year postpartum with maternal interviews, questionnaires, medical records abstraction, and a subset of infants who received a physical examination. Study outcomes were major structural birth defects, minor birth defects, pregnancy loss, preterm delivery, pre- and post-natal growth deficiency, serious or opportunistic infections, malignancies, and developmental milestones. In the overall registry, 17/275 (6.2%) of pregnancies were lost-to-follow-up. Among pregnancies ending in at least one liveborn infant, 7/94 (7.4%) in the vedolizumab-exposed cohort compared to 4/71 (5.6%) in the disease-matched cohort had a major birth defect (adjusted risk ratio [aRR] 1.07, 95% Confidence Interval [CI] 0.33, 3.52). Compared to the disease-matched cohort, women in the vedolizumab-exposed group were not statistically significantly more likely to experience spontaneous abortion (adjusted hazard ratio [aHR] 1.01, 95% CI 0.17, 5.89). Women in the vedolizumab-exposed group were slightly but not significantly more likely to deliver preterm (aHR 1.58, 95% CI 0.65, 3.82). No significant increased risks were noted with vedolizumab exposure for any of the other study outcomes. These data add reassuring evidence in support of the safety of vedolizumab in pregnancy.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nuria Perez-Diaz-Del-Campo, Gabriele Castelnuovo, Arianna Ferro, Gian Paolo Caviglia, Chiara Rosso, Eleonora Dileo, Marta Guariglia, Angelo Armandi, Francesca Saba, Giorgio Maria Saracco, Federica Barutta, Guglielmo Beccuti, Gabriella Gruden, Zobair M Younossi, Elisabetta Bugianesi
{"title":"Impact of MASLD and associated comorbidities on Cognitive and Health-related Quality of Life outcomes in a Mixed MASLD-T2DM Cohort.","authors":"Nuria Perez-Diaz-Del-Campo, Gabriele Castelnuovo, Arianna Ferro, Gian Paolo Caviglia, Chiara Rosso, Eleonora Dileo, Marta Guariglia, Angelo Armandi, Francesca Saba, Giorgio Maria Saracco, Federica Barutta, Guglielmo Beccuti, Gabriella Gruden, Zobair M Younossi, Elisabetta Bugianesi","doi":"10.14309/ajg.0000000000003594","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003594","url":null,"abstract":"<p><strong>Background aims: </strong>Metabolic dysfunction-associated steatotic liver disease (MASLD) coexists with multiple comorbidities that contribute to impaired vascular function, worsening cognitive impairment, and quality of life. This study aimed to evaluate the impact of MASLD and related comorbidities on cognitive function and health-related quality of life (HRQoL).</p><p><strong>Methods: </strong>A total of 601 overweight/obese patients with MASLD and/or Type 2 Diabetes Mellitus were included. Liver stiffness (LS) measurement and steatosis were assessed by transient elastography and controlled attenuation parameter (CAP), respectively. Cognitive function and HRQoL were evaluated using the RBANS and SF-36 questionnaires.</p><p><strong>Results: </strong>MASLD-related comorbidities were found to significantly and clinically affect cognitive function and HRQoL. Patients with severe steatosis (CAP≥300 dB/m, n=378) exhibited median cognitive scores falling into the abnormal range (p=0.056), with statistically significant lower scores in physical functioning (p<0.001), vitality (p=0.011), general health (p=0.001), and immediate memory (p=0.034), as well as a trend toward lower visuospatial/construction scores (p=0.058) than CAP<300 dB/m. Among patients with significant or high LS (LS≥8 kPa, n=69), lower physical functioning (p<0.001), higher limitations physical (p=0.004), and worse general health (p=0.011) were observed compared to those with LS<8 kPa. In the multivariate adjusted analyses, CAP≥300 dB/m was significantly associated with cognitive impairment (OR:1.42, 95% CI 1.0; 2.0, p=0.045), whereas LS≥8 kPa was associated with higher limitations physical (OR:1.9, 95% CI 1.1; 3.2, p=0.019).</p><p><strong>Conclusions: </strong>Our findings highlight the relationship between MASLD severity and impairment in cognitive function and HRQoL, underscoring its multifactorial nature. Specifically, severe hepatic steatosis may be a risk factor for cognitive decline, whereas significant or high liver stiffness appears to have a greater impact on HRQoL.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A Sidney Barritt, Elliot B Tapper, Philip N Newsome, Derek Gazis, Heather Morris, Andrea R Mospan, Anthony Daniel Perez, Yestle Kim, Brent A Neuschwander-Tetri, Rohit Loomba, Arun Sanyal
{"title":"Cardiovascular risk assessment tools are insufficient for patients with metabolic dysfunction associated steatotic liver disease.","authors":"A Sidney Barritt, Elliot B Tapper, Philip N Newsome, Derek Gazis, Heather Morris, Andrea R Mospan, Anthony Daniel Perez, Yestle Kim, Brent A Neuschwander-Tetri, Rohit Loomba, Arun Sanyal","doi":"10.14309/ajg.0000000000003595","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003595","url":null,"abstract":"<p><strong>Introduction: </strong>Risk for cardiovascular (CV) events is estimated by the Framingham Risk Score (FRS), Pooled Cohort Equation (PCE) and the American Heart Association Predicting Risk of CVD EVENTs (PREVENT) equation. The applicability of these risk tools in patients with MASLD is uncertain. This study sought to determine the accuracy of the FRS, PCE, and PREVENT in a real-world cohort of patients with MASLD.</p><p><strong>Methods: </strong>This analysis included US adults ≥ age 30 with MASLD in the TARGET-NASH study. Five to ten-year CV risk was estimated using original and recalibrated versions of the FRS and PCE, and original PREVENT equation. Discrimination among prediction models was assessed using Harrell's concordance statistic and calibration was evaluated using a modified Hosmer Lemeshow test comparing observed and predicted CV events. Logistic regression was used to assess the contribution of liver disease to observed CV events.</p><p><strong>Results: </strong>Overall, 1,090 patients were included. There was an increase in observed CV events from MASL to cirrhosis. FRS demonstrated a weak ability to identify patients who went on to experience a CV event (C-statistic 0.58, 95% CI 0.52-0.63) as did the AHA PREVENT model (C-statistic 0.60, 95% CI 0.54-0.65). Both the FRS and PCE demonstrated a significant lack of calibration (p<0.01), with overestimation in the highest deciles and underestimation in the lowest deciles of predicted risk.</p><p><strong>Conclusions: </strong>Commonly used tools to identify CV risk performed poorly in a cohort of patients with MASLD. As CV related death is the greatest source of mortality among patients with MASLD, better risk assessment tools are required.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association of GLP-1 Receptor Agonists with Liver-Related Outcomes and All-Cause Mortality in Patients with Harmful Alcohol Use: A Target Trial Emulation Study.","authors":"Binu V John, Dustin Bastaich, Daniella Marchetti, Ponni Perumalswami, Mixael Zirio Mustafa, Bassam Dahman","doi":"10.14309/ajg.0000000000003585","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003585","url":null,"abstract":"<p><strong>Background and aims: </strong>Anecdotal observations report a decrease in craving for alcohol among patients taking glucagon-like peptide-1 receptor agonists (GLP-1RA). We aimed to assess liver-related outcomes and mortality among individuals with harmful alcohol use who received GLP-1 RAs.</p><p><strong>Methods: </strong>We emulated a target trial using the electronic health records of U.S. Veterans with positive alcohol use disorders-concise score (AUDIT-C), comparing new initiators of GLP-1RA between 1/3/2017 and 9/30/2024, with controls, with follow-up until outcomes or study end. Each GLP-1 RA new user with a positive AUDIT-C screen was propensity score-matched 1:1 with a patient not on a GLP-1RA. The primary outcomes were the time to a composite outcome of decompensation, HCC, liver-related death, and all-cause mortality. The secondary outcome was the proportion of patients with positive AUDIT-C scores.</p><p><strong>Results: </strong>We matched 8040 patients with positive AUDIT-C initiated on GLP-1 RA with 8040 non-initiators. GLP-1 RA use was associated with a lower risk of composite liver-related outcomes (adjusted hazard ratio [aHR], 0.70; 95% CI 0.56-0.87), and death (aHR 0.43, 95% CI 0.37-0.49). Among Semaglutide users, a 1 mg/week dose increase was associated with a reduced risk of composite liver-related outcomes (aHR 0.50, 95% CI 0.29-0.88) and death (aHR 0.33, 95% CI 0.19-0.58). GLP-1 RA use was also associated with lower odds of positive AUDIT-C during follow-up (aOR 0.75, 95% CI 0.68-0.82).</p><p><strong>Conclusions and relevance: </strong>In this observational target trial emulation study, GLP-1 RA use was associated with a lower risk of liver outcomes, death, and harmful alcohol use.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144245781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohamed G Shiha, Annalisa Schiepatti, Francesca Manza, Stiliano Maimaris, Imran Aziz, David S Sanders
{"title":"Global prevalence of celiac disease in patients with Rome III and Rome IV irritable bowel syndrome: A systematic review and meta-analysis.","authors":"Mohamed G Shiha, Annalisa Schiepatti, Francesca Manza, Stiliano Maimaris, Imran Aziz, David S Sanders","doi":"10.14309/ajg.0000000000003586","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003586","url":null,"abstract":"<p><strong>Introduction: </strong>Irritable bowel syndrome (IBS) and celiac disease (CeD) are common disorders that share overlapping symptoms. In this systematic review and meta-analysis, we aimed to provide up-to-date and comprehensive estimates of the prevalence of CeD in patients with IBS.</p><p><strong>Methods: </strong>We searched several databases through January 2025 for studies reporting the prevalence of CeD in patients with IBS. Eligible studies used Rome III or Rome IV criteria for IBS diagnosis and used serological screening with tissue transglutaminase, endomysial antibodies, or deamidated gliadin peptide, and/or confirmatory duodenal biopsies for CeD diagnosis. We used random-effects meta-analysis to estimate the pooled prevalence of seropositive and biopsy-proven coeliac disease with 95% confidence intervals (CI). We calculated pooled odds ratios (ORs) to compare the likelihood of CeE between patients with IBS and controls.</p><p><strong>Results: </strong>A total of 29 studies comprising 7,209 patients with IBS were included. The pooled seroprevalence of CeD in patients with IBS was 6% (95% CI, 5% - 8%), and the pooled prevalence of biopsy-proven CeD was 2% (95% CI, 2% - 3%). A significant proportion of seropositive patients (15%; 95% CI, 6% - 24%) did not undergo endoscopy and biopsy. Patients with IBS had significantly higher odds of a positive serology than controls (OR 4.42; 95% CI, 2.82 - 6.92). The odds of CeD were similar across genders and IBS subtypes. There was a limited number of studies from Europe and no studies from the United States.</p><p><strong>Conclusion: </strong>CeD is highly prevalent in patients with IBS, according to the Rome III and Rome IV criteria. A positive diagnosis of IBS should not be made without excluding CeD.</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Keith L Obstein, Claire A Landewee, James Martin, Simone Caló, Joseph Norton, Jun Wai Kow, Bruno Scaglioni, Pietro Valdastri
{"title":"The Magnetic Flexible Endoscope: Phase 1 First-in-Human Clinical Trial.","authors":"Keith L Obstein, Claire A Landewee, James Martin, Simone Caló, Joseph Norton, Jun Wai Kow, Bruno Scaglioni, Pietro Valdastri","doi":"10.14309/ajg.0000000000003584","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003584","url":null,"abstract":"<p><strong>Background and aims: </strong>Magnetic actuation of endoscopes is promising-as the endoscope can be pulled from its front. Our team developed a novel Magnetic Flexible Endoscope (MFE) that uses magnetic field sensing, robotic control, and real-time image processing for colonoscopy. We conducted a Phase 1 first-in-human clinical trial to assess platform safety and tolerability.</p><p><strong>Methods: </strong>Platform: The MFE contains an internal permanent magnet, camera, illumination module, and channels for instruments, insufflation/camera cleaning, irrigation, and suction. A robotic arm maneuvers a second permanent magnet coupled to the MFE. System software facilitates controlled intelligent-magnetic actuation.</p><p><strong>Experiment: </strong>Five patients scheduled for screening colonoscopy (ICD-10 z12.11) were enrolled. Patients underwent standard of care colonoscopy with monitored anesthesia care. Upon withdrawal of the colonoscope, sedation was stopped, and after colonoscope removal, the MFE was inserted into the colon via the anus. The MFE was advanced through the colon while the patient was unsedated. After colon traversal, the MFE was withdrawn. Outcomes of interest included safety and tolerability of the MFE, participant sentiment via structured interview, platform usability, and robot pose data.</p><p><strong>Results: </strong>All patients underwent successful standard of care colonoscopy. All patients were awake and alert for MFE colonoscopy; tolerating the exam well without discomfort, pain, or other complaint. There were no adverse events or trauma. The system was robust without software or function failure.</p><p><strong>Conclusion: </strong>The MFE successfully traversed the human colon without adverse event or patient discomfort. System performance was successful without unanticipated events. This is the first time safety and tolerability of the novel platform has been demonstrated in vivo. ClinicalTrials.gov (NCT05833789).</p>","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The impact of violence and trauma on patient care: What the gastroenterologist needs to know.","authors":"Dr Christina Awad, Dr Mark Hubner","doi":"10.14309/ajg.0000000000003587","DOIUrl":"https://doi.org/10.14309/ajg.0000000000003587","url":null,"abstract":"","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}